Desderman n

INFORMATION ON OUTER PACKAGING
(label-leaflet)
BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

desderman N, (79 g + 0.10 g)/100 g, cutaneous solution
(Ethanolum + 2-Biphenylol)

2. CONTENT OF ACTIVE SUBSTANCES

Composition:
100 g of the skin solution contains:

• active substances: ethanol 96%, 79 g, contaminated with 1% methyl ethyl ketone, 2-phenylphenol, 0.10 g;

3. LIST OF EXCIPIENTS

• excipients: myristyl isopropylate, hexadecyl/octadecyl [(RS)-2-ethylhexanoate], povidone 30, sorbitol liquid, isopropyl alcohol, purified water

4. PHARMACEUTICAL FORM AND PACKAGE CONTENTS

Skin solution
150 ml Code: 5909990425464
450 ml Code: 5909990425471
500 ml Code: 5909990667666
1000 ml Code: 5909990425488

5. METHOD AND ROUTE OF ADMINISTRATION

For topical use only.
Read the entire leaflet before using the medicine.

6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT

KEEP OUT OF SIGHT AND REACH OF CHILDREN
Keep the medicine out of sight and reach of children.

7. OTHER SPECIAL WARNINGS, IF NECESSARY

Flammable medicinal product.

8. EXPIRY DATE

Expiry date:
Do not use this medicine after the expiry date.

9. SPECIAL STORAGE CONDITIONS

Storage conditions:
Store at a temperature below 25°C. Due to the low flash point (16°C), special safety precautions must be observed during use and storage.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED

MEDICINAL PRODUCT OR WASTE DERIVED FROM IT, IF
APPLICABLE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Marketing Authorisation Holder and Manufacturer
Schülke & Mayr GmbH
Robert Koch Strasse 2
22851 Norderstedt
Germany

12. MARKETING AUTHORISATION NUMBER

Authorisation number 13058

13. BATCH NUMBER

Batch number:

14. GENERAL AVAILABILITY CATEGORY

OTC - Medicinal product available without a prescription.

15. INSTRUCTIONS FOR USE

Mechanism of action:
Desderman N acts bactericidally, fungicidally, and virucidally.
Desderman N is effective against microorganisms such as Gram-positive bacteria (including staphylococci, including MRSA; streptococci, including vancomycin-resistant enterococci), Gram-negative bacteria (including Escherichia coli, Pseudomonas aeruginosa, Proteus vulgaris, Proteus mirabilis, Helicobacter pylori, and Listeria monocytogenes) as well as mycobacteria (including Mycobacterium tuberculosis).
Desderman N acts fungicidally, inter alia against yeasts (including Candida albicans).
The product acts virucidally against, inter alia, hepatitis B virus, rotaviruses, adenoviruses, herpes simplex (HSV), and poliovirus.
Desderman N also contains moisturizing and emollient excipients which prevent drying of the hands and maintain skin elasticity.

Indications:
Desderman N is an alcohol-based solution for hygienic and surgical antisepsis of the hands.

When not to use Desderman N:
Do not use in case of hypersensitivity to ethanol, biphenoxyol, or to any of the excipients of the product.

Directions for use:
Hygienic hand antisepsis:
Apply 3 ml of Desderman N in portions and rub into dry hands for 30 seconds.

Surgical antisepsis of hands:
Apply 10 ml of Desderman N in portions onto washed, dry hands and forearms, rubbing for 90 seconds, ensuring continuous wetting of the skin with the product.
Wait until hands are completely dry before putting on gloves.

Warnings and precautions:
Before starting use of Desderman N, consult with a physician or pharmacist.
Avoid contact of the product with eyes and mucous membranes.
If used in a manner inconsistent with the indications and instructions for use, the alcohols contained in the product may cause irritation or be absorbed through the skin, especially damaged skin, and may lead to systemic effects.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a physician or pharmacist before using this product.

Desderman N and other medicinal products
Inform the physician about all medicinal products currently or recently used, as well as those planned for use.

Driving and operating machinery
No studies on the effect of the product on the ability to drive or operate machinery have been conducted.

Use of a higher than recommended dose of Desderman N:
In case of use of a higher than recommended amount of the product or ingestion of the product, contact a physician immediately.

Possible adverse reactions
Like all medicinal products, this product may cause adverse reactions, although they do not occur in all patients.
Dryness and irritation of the skin may occur. Rarely, allergic contact dermatitis or contact urticaria may occur.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a physician, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel. (22) 49 21 301, fax (22) 49 21 309,
website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to obtain further information on the safety of the product.

For more detailed information, contact the local representative of the marketing authorization holder:
Schulke Polska Sp. z o.o.
02-305 Warsaw
Al. Jerozolimskie 132
tel. 022-11-60-700, fax: 022-11-60-701

Date of the latest text revision:

16. INFORMATION PROVIDED IN BRAILLE

desderman N

17. UNIQUE IDENTIFIER – 2D CODE

Not applicable.

18. UNIQUE IDENTIFIER – HUMAN-READABLE INFORMATION

Not applicable.
INFORMATION ON OUTER PACKAGING
(label-leaflet)
CANISTER

1. NAME OF THE MEDICINAL PRODUCT

Desderman N, (79 g + 0.10 g)/100 g, solution for skin application
(Ethanol + 2-Biphenylol)

2. CONTENT OF ACTIVE SUBSTANCES

Composition:
100 g of skin solution contains:

• active substances: ethanol 96%, 79 g, contaminated with 1% methyl ethyl ketone, 2-phenylphenol, 0.10 g;

3. LIST OF EXCIPIENTS

• excipients: myristyl isopropylate, hexadecyl/octadecyl [(RS)-2-ethylhexanoate], povidone 30, sorbitol liquid, isopropyl alcohol, purified water

4. PHARMACEUTICAL FORM AND CONTENTS OF THE CONTAINER

Topical solution
5000 ml Code: 5909990425501

5. METHOD AND ROUTE OF ADMINISTRATION

For topical use only.
Please read the entire leaflet before using the medicine.

6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT

KEEP OUT OF SIGHT AND REACH OF CHILDREN
Store in a place out of sight and reach of children.

7. OTHER SPECIAL WARNINGS, IF NECESSARY

Flammable medicinal product.

8. EXPIRY DATE

Expiry date:
Do not use this medicine after the expiry date has passed.

9. SPECIAL STORAGE CONDITIONS

Storage conditions:
Store below 25°C. Due to the low flash point (16°C), special safety precautions must be observed during use and storage.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED

MEDICINAL PRODUCT OR WASTE DERIVING FROM SUCH MEDICINAL PRODUCT, IF
APPLICABLE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Marketing Authorisation Holder and Manufacturer
Schülke & Mayr GmbH
Robert Koch Strasse 2
22851 Norderstedt
Germany

12. MARKETING AUTHORISATION NUMBER

Authorisation number 13058

13. BATCH NUMBER

Batch number:

14. GENERAL AVAILABILITY CATEGORY

OTC - Medicinal product available without a prescription.

15. INSTRUCTIONS FOR USE

Mechanism of action:
Desderman N acts as a bactericidal, fungicidal, and virucidal agent.
Desderman N is effective against microorganisms including Gram-positive bacteria (e.g. staphylococci, including MRSA; streptococci, including vancomycin-resistant enterococci), Gram-negative bacteria (e.g. Escherichia coli, Pseudomonas aeruginosa, Proteus vulgaris, Proteus mirabilis, Helicobacter pylori, and Listeria monocytogenes) as well as mycobacteria (including Mycobacterium tuberculosis).
Desderman N has fungicidal activity, particularly against yeasts (including Candida albicans).
It also exhibits virucidal activity against, among others, hepatitis B virus, rotaviruses, adenoviruses, herpes simplex (HSV), and poliovirus.
Desderman N also contains moisturizing and emollient excipients which prevent drying of the hands and help maintain skin elasticity.

Indications:
Desderman N is an alcohol-based solution for hygienic and surgical antisepsis of the hands.

When not to use Desderman N:
Do not use in case of hypersensitivity to ethanol, biphenoxyol, or to any of the excipients of the medicinal product.

Instructions for use:
Hygienic hand antisepsis:
Apply 3 ml of Desderman N in portions and rub into dry hands for 30 seconds.
Surgical hand antisepsis before surgical procedures:
Apply 10 ml of Desderman N in portions to clean, dry hands and forearms and rub in for 90 seconds, ensuring continuous wetting of the skin with the product.
Wait until hands are completely dry before putting on gloves.

Warnings and precautions:
Before starting use of Desderman N, consult a physician or pharmacist.
Avoid contact of the product with eyes and mucous membranes.
If the product is used in a manner inconsistent with the indications and instructions for use, the alcohols contained in the product may cause irritation or be absorbed through the skin, especially damaged skin, potentially leading to systemic effects.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a physician or pharmacist before using this medicinal product.

Desderman N and other medicinal products
Inform the physician about all medicinal products currently or recently used, as well as any medicinal products planned for use.

Driving and operating machinery
No studies on the effect of the medicinal product on the ability to drive or operate machinery have been conducted.

Use of a higher than recommended dose of Desderman N:
In case of application of a larger than recommended amount of the product or ingestion of the product, contact a physician immediately.

Possible adverse reactions
Like all medicinal products, this product can cause adverse reactions, although not everybody will experience them.
Dryness and skin irritation may occur. Rarely, allergic contact dermatitis or contact urticaria may occur.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a physician, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel. (22) 49 21 301, fax (22) 49 21 309,
website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the responsible entity.

Reporting adverse reactions helps to provide more information on the safety of the medicinal product.

For more detailed information, contact the local representative of the responsible entity:
Schulke Polska Sp. z o.o.
02-305 Warsaw
Al. Jerozolimskie 132
tel. 022-11-60-700, fax: 022-11-60-701

Date of last revision of the text:

16. INFORMATION PROVIDED IN BRAILLE

Desderman N

17. UNIQUE IDENTIFIER – 2D CODE

Not applicable.

18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA

Not applicable.